Description

Cefepime Impurity 3 is a specified impurity and degradation product of the fourth-generation cephalosporin antibiotic, Cefepime. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefepime API and its finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefepime Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Cefepime during stability studies and release testing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to confirm the impurity profile of Cefepime batches complies with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Cefepime, leading to improved formulation strategies.

Basic Information

Product Name	Cefepime Impurity 3
CAS No.	1338535-10-6
Molecular Formula	C19H24N6O5S2
Molecular Weight	480.57 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Cefepime Related Compound C; Cefepime EP Impurity C; Cefepime USP Related Compound C; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium; Cefepime Impurity C (EP); Cefepime N-Oxide Impurity
EINECS	Contact for details

Quality Control

Our Cefepime Impurity 3 is manufactured and controlled under a strict quality management system. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.